Collection well for body fluid tester

ABSTRACT

A body fluid is collected for testing for an analyte contained within the body fluid. The fluid is collected in an apparatus including a reservoir for receiving and collecting a flow of body fluid from a discharge end of a conduit. A capillary test space is in fluid flow communication with the reservoir. The capillary test space is positioned to be in contact with the fluid in the reservoir after the fluid has accumulated to a predetermined transfer volume of fluid. The capillary test space is sized to wick the fluid from the reservoir when the fluid contacts the capillary test space.

This application is a of U.S. patent application Ser. No. 09/513,013,filed Feb. 25, 2000, U.S. Pat. No. 6,375,626, which is aContinuation-In-Part of U.S. patent application Ser. No. 09/267,179,filed Mar. 12, 1999, U.S. Pat. No. 6,368,563, the disclosures of whichare hereby incorporated by reference.

TECHNICAL FIELD

This invention pertains to testing a body fluid for an analyte. Forexample, the present invention is applicable for testing glucose in abody fluid such as blood or interstitial fluid.

BACKGROUND

Numerous patents teach various ways for collecting a sample of bodyfluid and testing such fluid for an analyte such as glucose. Forexample, U.S. Pat. Nos. 5,823,973 and 5,820,570 describe methods andapparatus for obtaining, in one embodiment, interstitial fluid, which istested for glucose through IR absorption. These patents also describeuse of the disclosed inventions in colormetric and electro-chemicaltesting of glucose. U.S. Pat. No. 5,453,360 teaches a test strip forcolormetric testing for glucose. Blood is placed on a test stripcontaining various chemical components including a dye. The degree ofcolor change of the test strip indicates the amount of glucose. U.S.Pat. Nos. 5,508,171 and 5,628,890 teach electro-chemical testing. Bloodis placed on a test strip containing electrodes. Reaction of glucose onthe electrodes generates a current indicating the amount of glucosepresent in the blood.

Present development efforts are directed to testing very small volumesof body fluid (e.g. about 0.5 microliter). The use of such small volumesof fluid permits less painful collection of a fluid samples. However,small fluid volumes present additional challenges for analyte testing.For example, testing for analytes typically requires a fluid sample inexcess of a predetermined minimum volume. By way of non-limitingrepresentative example, a test may require a minimum sample size of 5microliter to yield reliable test results.

Furthermore, sample collection systems may receive a flow of body fluidover an extended time (e.g., 10 seconds or more) before a minimum samplevolume is collected. As a result, body fluid may be deposited on testcomponents (e.g., electrodes or colormetric test strips) before a fullsample is collected. Such premature deposit may initiate chemicalreactions on a test strip thereby consuming reagents before a reliabletest can be initiated. Further, such test components may be coupled tologic circuits for calculating an analyte's concentration based onreadings from the test strip. A premature deposit of an inadequatevolume of fluid sample may falsely inform logic circuits that testinghas initiated when, in fact, an adequate sample volume has yet to becollected.

Recognizing the problems of premature test initiation, the prior art hasdeveloped techniques for delaying test initiation until an adequatevolume of sample is collected. For example, logic circuits may have abuilt-in time delay which assumes a fixed period of time to collect anadequate volume of sample. Of course, such systems suffer from the factthere is no certainty that an adequate volume is collected during suchtime delay. Alternatively, to be conservative, such time delays mayfrequently be unnecessarily long. Additionally, U.S. Pat. No. 5,049,487teaches reading a reflectance of a side of a membrane. A fluid sample isplaced on the opposite side. When the sample is absorbed through themembrane, the change in reflectance is noted indicating testing maycommence. However, such a system suffers from chemical agents on themembrane being in contact with a sample prior to initiating testing.

Therefore, there is a need for a method and apparatus for collecting asample of body fluid to obtain an adequate volume of such fluid.

SUMMARY

According to a preferred embodiment of the present invention, a methodand apparatus are disclose for collecting a body fluid for testing foran analyte contained within the body fluid. The apparatus includes areservoir for receiving and collecting a flow of body fluid from adischarge end of a conduit. A capillary test space is in fluid flowcommunication with the reservoir. The capillary test space is positionedto be in contact with the fluid in the reservoir after the fluid hasaccumulated to a predetermined transfer volume of fluid. The capillarytest space is sized to wick the fluid from the reservoir when the fluidcontacts the entrance end. With the present invention, fluid iscollected within the reservoir at a rate of flow limited by the conduit.When the reservoir is full, the collected fluid rapidly wicks into thecapillary test space. The capillary test space may contain testcomponents for testing for the analyte.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a sample collection apparatus with anelectro-chemical test strip shown removed;

FIG. 2 is an enlarged segmented view of the area of circle 2 in FIG. 1;

FIG. 3 is a side-sectional view of the apparatus of FIG. 1 showing thetest strip in place;

FIG. 4 is an enlarged segmented view of the area of circle 4 in FIG. 3;

FIG. 5 is a segmented top-plan view of a reservoir of the apparatus ofFIG. 1;

FIG. 6 is a view taken along line 6—6 in FIG. 3 and showing a bolus ofbody fluid residing in a capillary test space;

FIG. 7 is a top plan view of a first alternative embodiment of thepresent invention;

FIG. 8 is a view taken along line 8—8 of FIG. 7;

FIG. 9 is a view similar to FIG. 8 showing a second alternativeembodiment of the present invention;

FIG. 10 is a view similar to those of FIGS. 8 and 9 showing a thirdalternative embodiment of the present invention;

FIG. 11 is a top plan view of the embodiment of FIG. 10 with a teststrip removed;

FIG. 12 is a view similar to FIG. 11 showing a fourth alternativeembodiment of the present invention;

FIG. 13 is a bottom, rear end and right side perspective view of a stillfurther embodiment of a sample collection apparatus according to thepresent invention;

FIG. 14 is a right side elevation view of the apparatus of FIG. 13;

FIG. 15 is a rear end elevation view of the apparatus of FIG. 13;

FIG. 16 is a view taken along line 16—16 in FIG. 14; and

FIG. 17 is a view taken along line 17—17 in FIG. 15.

DETAILED DESCRIPTION

With reference to the various drawing figures in which identicalelements are numbered identically throughout, a description of apreferred embodiment will now be provided. Throughout this description,the present invention will be described with reference to collecting asample of interstitial fluid for glucose testing using a narrow needlethat penetrates into, but not through, the dermis as more fullydescribed in commonly assigned U.S. Pat. Nos. 5,823,973 and 5,820,570,the disclosures for both of which are hereby incorporated herein byreference. While such a use is a preferred embodiment, the presentinvention is applicable to other fluid collection systems (e.g., bloodcollection) as well as testing for other fluid analytes. Further, thepresent invention is described with reference to using electro-chemicaltesting of a collected sample. The teachings of the present inventionare equally applicable to other testing methods such as colormetrictesting and IR absorption testing.

Referring now to FIGS. 1-6, a collection apparatus 10 includes a mainbody 12 and a test strip 14. The main body has a handle 16 and aneedle-containing ferrule 18. The ferrule 18 holds a hollow needle 20extending from a penetration end 22 to a discharge end 24. Thepenetration end 22 protrudes from a radially spaced ring end 26 of theferrule 18.

In a preferred embodiment, the penetration end 22 is axially spaced fromring end 26 by a distance sufficient for the needle 20 to penetrate intobut not through a patient's dermis to collect a sample of substantiallyblood-free interstitial fluid as taught in U.S. Pat. No. 5,820,570. Insuch an embodiment, the outer diameter of the needle is about 0.013 inch(about 0.33 mm). This sizing of the needle permits substantiallypain-free penetration of the needle to collect a body fluid. Thisdescription illustrates a preferred embodiment. Needle 20 may be sizedto collect any body fluid such as blood or interstitial fluid. Further,the present invention is disclosed where the skin penetration member(i.e., the needle 20) also serves as a conduit for supplying fluid to areservoir 30 as will be described. The present invention is alsoapplicable to any conduit for transporting a body fluid (e.g., acapillary tube as described in International Application PCT/US97/08400published Nov. 20, 1997 as International Publication No. WO 97/42883).

The test strip 14 contains exposed test components on an inner surface14 a. The test components are shown in the form of electrodes 32 fortesting a body fluid for an analyte such as glucose throughelectro-chemical testing. As previously described, the test componentscould be components for alternate testing techniques such as colormetricor IR absorption testing.

Not shown is a housing for holding the apparatus 10 during samplecollection and testing. Housings for holding disposable body fluidsamplers are shown in U.S. Pat. No. 5,823,973. Such housings may containelectrical components for electrical connection to the test stripelectrodes 32 to connect a signal from the electrodes 32 to logiccircuits to compute and report on the analyte in response to signalsfrom the electrodes 32 during testing.

The material of the main body 12 defines a cylindrical reservoir 30having a cylindrical axis between a first end 34 and a second end 36. Inthe embodiment shown, the axis of the reservoir 30 is perpendicular tothe axis of the needle 20. Such a relative alignment is not necessaryfor adequate function and any other alignment is acceptable.

The reservoir 30 has a volume at least as great as a desired test volumeof body fluid to be tested. In a preferred embodiment, reservoir 30 hasa volume of 0.7 microliters. As will become apparent, fluid is collectedin the reservoir 30 and accumulates with a fluid level rising from thefirst end 34 toward the second end 36. Due to such small volumes and thegeometry of reservoir 30, surface tension assures the fluid is retainedin the reservoir 30 with the fluid level rising as described regardlessof the orientation of the apparatus 10 (i.e., the operation of theapparatus 10 is gravity independent).

The discharge end 24 of the needle 20 is disposed within the reservoir30 adjacent the first end 34. Accordingly, body fluid is transportedfrom the penetration end 22, through needle 20 and discharged from thedischarge end 24 into the reservoir 30 at the first end 34.

The material of the body 12 also defines an enlarged empty volume 38positioned between the reservoir 30 and the ferrule 18 and surroundingthe needle 20. The enlarged volume 38 is separated from the reservoir 30by material of the main body pinching against the needle 20 as atlocations 40. The enlarged volume 38 has a volume larger than thereservoir 30 and ensures that fluid within the reservoir 30 is retainedwithin reservoir 30 as it accumulates. For example, in the absence ofenlarged volume 38, manufacturing tolerances may result in a narrowspacing between the material of main body 12 and needle 20. Such anarrow spacing could function as a capillary space communicating withreservoir 30 which would wick fluid out of reservoir 30. The enlargedvolume 38 precludes such capillary wicking. Further, the materialdefining the volume 38 is preferably hydrophobic to minimize wicking. Inthe event precise manufacturing permits complete liquid-tight sealingaround needle 20, the enlarged volume 38 could be eliminated.

The test strip 14 is secured to the main body (e.g., through adhesives)with the inner surface 14 a facing the main body 12 and overlying thesecond end 36 of the reservoir 30. The main body 12 includes a groove 42shaped complementary to the outer periphery of the test strip 14 toensure accurate alignment of the test strip 14 with the main body 12.Adjacent its outer periphery, the inner surface 14 a of the test strip14 includes spacers 44 (shown best in FIG. 6). The spacers 44 insureuniform and close parallel spacing of the inner surface 14 a from a teststrip opposing surface 12 a of the main body 12 for reasons that willbecome apparent. Alternatively, spacers could be formed on the body 12thereby eliminating the need for spacers 44.

The test strip opposing surface 12 a includes a step 46. With referenceto FIG. 6, the construction described above results in formation of acapillary test space 48 defined between opposing surfaces of the teststrip inner surface 14 a and step 46.

As shown in FIG. 6, the spacers 44 are spaced from opposing surfaces ofthe step 46 thereby defining enlarged volumes 50 on opposite sides ofthe step 46. The enlarged volumes 50 perform a function similar to thatof enlarged volume 38. Namely, if the spacers 44 were sized to abut step46, small capillary spaces could form between the spacers 44 and step46. Such capillary spaces could wick fluid from the fluid receivingvolume 48. Again, if manufacturing could ensure a fluid-tight sealbetween spacers 44 and step 46, the volumes 50 could be eliminated.

Shown best in FIGS. 4 and 6, the electrodes 32 are positioned opposingthe step 46. Further, the spacing S (FIG. 4) between the step 46 andinner surface 14 a is uniform and is selected to be sufficiently narrowfor the capillary test space 48 to act as a capillary space to wickfluid from the reservoir 30. An entrance end 52 of the capillary testspace 48 is positioned at the second end 36 of the reservoir 30 (FIG.4). The preferred spacing S is about 0.003-0.005 inch (about 0.075 mm to0.125 mm). The spacing S may be as large as 0.012 inch (about 0.300 mm)or larger depending on the surface tension and volume of the fluid beingcollected and the relative hydrophobic/hydrophilic characteristics ofthe main body 12 and test strip 14.

A hole 54 is formed through the body 12 and into the fluid receivingvolume 48 on a side of the step 46 opposite the reservoir 30. The hole54 permits air in the capillary test space 48 to be vented to atmosphereas fluid flows into the capillary test space 48 from the reservoir 30.Volumes 50 also provide venting.

With the construction thus described, the apparatus 10 is used by urgingthe ring end 26 against a patient's skin. The penetration tip 22penetrates the skin. The ring end 26 (being radially spaced from tip 22)acts to urge fluid into the needle 20. The fluid flows along the needle20 and discharges into the first end 34 of the reservoir 30 throughdischarge end 24. In one possible embodiment, suction could be appliedto advance the rate of flow of fluid through needle 20. Suction is notused in other embodiments.

Fluid accumulates in the reservoir 30 with a level of accumulated fluidgrowing from the first end 34 to the second end 36. When the fluid levelreaches the second end 36, a desired volume of fluid to be tested hasaccumulated in the reservoir 30. At this time, the fluid level contactsthe entrance end 52 of the capillary test space 48. Since the capillarytest space 48 is a narrow capillary space, the fluid is rapidly wickedout of the reservoir 30 and into the capillary test space 48 as a bolusdelivery of fluid indicated by the bolus of fluid 56 in FIG. 6. Sopositioned, the fluid is in contact with the electrodes 32 and testingof the fluid may commence.

The present invention permits fluid contact with the electrodes 32 onlyafter an adequate volume of fluid has been collected. By way ofnon-limiting representative example, it may take thirty seconds forfluid to fill the reservoir 30 and only one second for the accumulatedfluid to be wicked into the capillary test space 48 from the reservoir30. As a result, the present invention avoids a long period of timeduring which fluid is contacting the electrodes 32 and before testingmay commence. Further, without the need for specialized electronics asused in the prior art, testing cannot commence until after an adequatevolume of fluid has been accumulated. Therefore, when a signal isreceived from electrodes 32, it is known that an adequate volume offluid is opposing the electrodes 32.

The retention of fluid in the reservoir 30 and wicking of fluid into thecapillary test space 48 can be controlled and modified by varying thedimensions of the components as will be apparent to one of ordinaryskill in the art having the benefit of the teachings of the presentinvention. Further, as will be apparent to such artisan, such retentionand wicking may also be controlled and modified through materialselection. For example, it is desirable that the main body 12 be formedof hydrophobic material and that the capillary test space 48 be morehydrophilic. For example, a hydrophilic surfactant may be applied tostep 46 or test strip inner surface 14 a (or both) to make the capillarytest space 48 more hydrophilic than the reservoir 30.

It may be desirable to have one of electrodes 32 completely wetted withfluid from reservoir 30 before the other of the electrodes 30 is wetted.FIGS. 7-12 illustrate several alternative embodiments for achieving suchsequential wetting. In the embodiments, elements in common with thosealready described are numbered identically with the addition of lettersuffices (i.e., “a”, “b”, “c” and “d”). Such elements are not separatelydescribed unless modified by the alternative embodiment.

In FIGS. 7 and 8, it is desirable to completely wet electrode 32 abefore wetting electrode 32 a′. The electrodes 32 a, 32 a′ arepositioned side-by-side on test strip 14 a and equidistant fromreservoir 30 a. As shown in FIG. 8, the step 46 of the previouslydescribed embodiment is divided into two steps 46 a, 46 a′ opposingrespective ones of electrodes 32 a, 32 a′. A hydrophobic volume 50 a′ ispositioned between the steps 46 a, 46 a′. The volume 50 a′ functionssimilarly to side volumes 50 a (and 50 in the embodiment of FIG. 6) toact as a hydrophobic barrier to prevent fluid from flowing between thesteps 46 a, 46 a′. The steps 46 a, 46 a′ are spaced from test strip 14by spaces Sa and Sa′. Since space Sa is smaller than space Sa′, fluidfirst flows from reservoir 30 a into space Sa before flowing fromreservoir 30 a into space Sa′.

In the embodiment of FIG. 9, fluid is inclined to first flow onto step46 b before onto step 46 b′. However, in FIG. 9, the volume barrier 50a′ of FIG. 8 has been replaced with a ramp surface 47 b connecting steps46 b and 46 b′. Therefore, fluid can flow from space Sb to space Sb′after space Sb has first filled with fluid.

In the embodiment of FIGS. 10 and 11, the steps 46 c, 46 c′ arepositioned on opposite sides of the reservoir 30 c. If spaces Sc and Sc′are equal, fluid flows simultaneously into the spaces Sc and Sc′ butdoes not flow between the spaces Sc and Sc′. The spaces Sc and Sc′ maybe varied to change the rate of flow into the spaces Sc and Sc′.

The embodiment of FIG. 12 is similar to that of FIG. 9. Instead of theramp 47 b of FIG. 9 (which connects steps 46 b and 46 b′ directly acrossa side-to-side path), the ramp 47 d is U-shaped for fluid to flow fromstep 46 d to step 46 d′ in a U-shaped path A on a side of the steps 46d, 46 d′ opposite the reservoir 30 d.

In FIGS. 1-6, the needle 20 is parallel to the plane of the capillaryspace 48 (as best illustrated in FIG. 4). FIGS. 13-17 illustrate anembodiment with the needle 20″ perpendicular to a capillary space 48″(shown in FIGS. 16 and 17). In FIGS. 13-17, a plastic main body 12″includes a planar handle strip 13″ and a perpendicular hollow hub 15″ orpeg extending from a first or bottom side 13 a″ of the strip 13″. A bore17″ (FIGS. 16 and 17) extends trough the hub 15″ and through the strip13″ to be exposed on a second or top side 13 b″ of the strip 13″.

Best shown in FIGS. 16 and 17, a test membrane 14″ is placed on thesecond side 13 b″ overlying the bore 17″. A cover 19″ is adhered to thetest membrane 14″ by an adhesive layer 21″.

The main body 12″ is sized to be placed in a monitor (not shown) withthe test membrane 14″ in alignment with test apparatus carried by themonitor. For example, the test membrane 14″ is aligned with opticcomponents for colormetric testing. In such an embodiment, the cover 19″has a hole 23″ to expose the test membrane 14″ overlying the bore 17″.In alternative embodiments, the test membrane 14″ can also be alignedwith electrodes for electro-chemical testing or with optic componentsfor infrared testing.

The needle 20″ is surrounded by a ferrule 18″. The ferrule 18″ holds theneedle 20″ with a distal tip 22″ (i.e., a penetration end) extendingfrom the ferrule 18″. The needle 20″ terminates at a discharge end 24″(numbered only in FIGS. 16 and 17). The penetration end 22″ protrudesfrom a radially spaced ring end 26″ of the ferrule 18″. To enhance fluidcollection, distal tip 22″ is bent as is more fully described incommonly assigned U.S. patent application Ser. No. 09/427,161 filed Oct.26, 1999 (also filed Jan. 26, 2000 as PCT/US00/02086. The ferrule 18″has a slot 25″ to expose needle 20″ so that adhesive can be applied tothe needle 20″ to adhere the needle 20″ to the ferrule 18″ duringassembly.

Shown only in phantom lines in order to better illustrate internalfeatures, an adapter 27″ is provided to connect the ferrule 18″ to thehub 15″ with the needle 20″ coaxially aligned with the bore 17″. Thedischarge end 24″ is positioned in the bore 17″ near a distal end 17 a″of the bore 17″ (as shown in FIGS. 16 and 17). The needle 20″ is asmaller diameter than the bore 17″ to define an annular space 29″surrounding the discharge end 24″. A vent opening 31″ (shown in FIGS. 15and 17) is formed through the cylindrical wall of the hub 15″ at thedistal end 17 a″ and in communication with the annular space 29″.

The test membrane 14″ is spaced from the second side 13 b″ of the strip13″ to define a capillary space 48″ (shown in FIGS. 16 and 17) betweenthe membrane 14″ and the second side 13 b″. The capillary space 48″overlies the bore 17″. Accordingly, as in previously describedembodiments, fluid flows from the needle 20″ through the discharge end24″ and into the bore 17″ which acts as a collection well or reservoiras in the reservoir 30 of the previously described embodiment. When thebore 17″ fills, the fluid contacts the capillary space 48″ and israpidly wicked into the capillary space 48″ and absorbed into the testmembrane 14″. A porous wick material 33″ (e.g., a porous polyesterlayer) fills the capillary space 48″ to assist in uniform distributionof fluid onto the membrane 14″.

Preferably (but not necessarily), the hub is hydrophobic. The surfacetension of the fluid prevents the fluid from discharging through thenarrow annular space 17″ or vent hole 31″. Vent holes 37″ are formedthrough the strip 13″ from the capillary space 48″. When fluid is wickedfrom the collection well or bore 17″ into the capillary space 48″, thevent holes 37″ permit air to escape from the capillary space 48″.Simultaneously, the vent hole 31″ permits a larger volume of air toenter the bore 17″ so that the capillary wicking of the fluid is notacting against a vacuum. Vent hole 17″ is optional since the annularspace 17″ also provides a venting opportunity utilizing air flow throughspacing tolerances in the ferrule 18″ and adapter 27″. The adapter 27″may be provided with a vent slot 41″ (FIG. 13) to admit air to vent 31″and space 17″.

From the foregoing detailed description, the present invention has beendescribed in a preferred embodiment. Modifications and equivalents ofsuch disclosure are intended to be included in the appended claims. Forexample, either or both of the reservoir 30 and capillary test space 48need not be an empty volume but could be filled with an absorbentmaterial.

The claimed invention is:
 1. An apparatus for collecting a body fluidfor testing for an analyte contained within said body fluid, saidapparatus comprising: a conduit having a first end for admitting a bodyfluid and transporting said body fluid from said first end to adischarge end of said conduit; a reservoir for receiving and collectinga flow of body fluid from said discharge end of said conduit; a testspace positioned to be in contact with said fluid in said reservoirafter said fluid has accumulated within said reservoir to a transfervolume of fluid, said test space positioned for said fluid in said testspace to be exposed to analyte testing components; said test spacehaving a test space volume for residence of said fluid in said testspace exposed to said components and with said transfer volume at leastas great as said test space volume; said test space adapted to passivelywick said fluid from said reservoir into said test space at a rate offlow greater than a rate of flow of said fluid into said reservoir fromsaid discharge end of said conduit when said fluid in said reservoirattains said transfer volume; and said reservoir sized for fluid to flowinto said reservoir from said conduit and be accumulated in saidreservoir until attainment of said transfer volume.
 2. An apparatusaccording to claim 1 wherein said reservoir and test space are arrangedso that fluid flows from said reservoir to said test space uponaccumulation of a volume of fluid in said reservoir being substantiallyequal to said transfer volume of fluid.
 3. An apparatus according toclaim 2 wherein said transfer volume of fluid is equal to or less thanabout 1 microliter.
 4. An apparatus according to claim 1 wherein saidreservoir has a volume and geometry so that fluid within said reservoirhas a surface tension sufficient to retain the fluid within saidreservoir regardless of the orientation of said reservoir.
 5. Anapparatus according to claim 1 wherein said conduit is in direct fluidcommunication with said reservoir.
 6. An apparatus according to claim 5wherein said reservoir is in direct fluid communication with said testspace.
 7. An apparatus according to claim 6 wherein said reservoir is indirect fluid communication with said test space volume.
 8. An apparatusaccording to claim 1 wherein said test space is a capillary test space.9. An apparatus according to claim 8 further comprising two opposingsurface, said two opposing surfaces at least partially forming saidcapillary test space, said two opposing surfaces separated by a gap ofabout 0.3 mm or less.
 10. An apparatus according to claim 9 wherein saidgap between said two opposing being in said range from about 0.075 mm toabout 0.125 mm.
 11. An apparatus according to claim 8 furthercomprising: test components within said capillary test space for testingsaid fluid for said analyte.
 12. An apparatus according to claim 11wherein: said test components include electrodes for electro-chemicallytesting said fluid; and said electrodes positioned within said capillarytest space to be in contact with said fluid after said fluid is wickedinto said capillary test space.
 13. An apparatus according to claim 8wherein said capillary test space is vented.
 14. An apparatus accordingto claim 8 wherein material defining said capillary test space is morehydrophilic than material defining said reservoir.
 15. An apparatusaccording to claim 1 wherein said test space is a capillary test spacedefined by an absorbent material in said test space to rapidly drawfluid from said reservoir into said capillary test space through passivecapillary action.
 16. An apparatus according to claim 1 wherein saidtest components are located within said test space for testing saidfluid for said analyte.
 17. An apparatus according to claim 16 whereinsaid test components include electrodes for electro-chemically testingsaid fluid, said electrodes positioned within said test space to be incontact with said fluid after said fluid is wicked into said test space.18. An apparatus according to claim 1 wherein: said conduit is a needleextending from a penetration end to said discharge end; and said needlepenetration end being exposed for penetration into a patient's skin toaccess body fluid for said fluid to flow along said needle anddischarged into said reservoir at said discharge end.